A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type a for Injection (CU-20101)

• Status: ACTIVE_NOT_RECRUITING
• Trial end date: 2026-05-01

Summary

This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines. The study consisted of a 7-day screening period, Study Part 1 (randomized double-blind controlled study) and Period 2 (open-label study). Part I was a multicenter, randomized, double-blind, single-injection, active-drug parallel-controlled, non-inferiority design clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20101 in the treatment of moderate to severe glabellar stria compared with a single injection of Botox®; part 2 was an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines.

• Phase: PHASE3

Details

• Lead Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd